REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS The Revolution XR/d with Tomosynthesis…

Date posted by the FDA

Feb. 21, 2012

Status

Terminated

Filed by

GE Healthcare, LLC

Product

REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS The Revolution XR/d with Tomosynthesis is intended for use in generating Tomographic images of human anatomy. It is not intended for mammographic use.

Reason

GE Healthcare has become aware of a potential issue associated with the hand grip that is clamped to the table top of your Revolution XRD X-ray systems that may impact patient safety. The hand grip accessory that is clamped to the table top may not be properly adjusted and can dislodge during use. Should this happen during patient loading or unloading, patient injury could occur.

Distribution pattern

Worldwide Distribution - USA including AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WY, WI and the countries of VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TAIWAN, SWITZERLAND, SPAIN, SLOVENIA, SAUDI ARABIA, REPUBLIC OF KOREA, NORWAY, NEW ZEALAND, NETHERLANDS, MALTA, KUWAIT, JORDAN, JAPAN, ITALY, ISRAEL, HONG KONG, GERMANY, FRANCE, ECUADOR, DENMARK, CZECH REPUBLIC, CHINA, CHILE, CANADA, and AUSTRALIA.

Quantity

772

Codes and lots

Serial Number 000000PROTOHL3 00000002400HL9 00000013894HL1 00000013895HL8 00000014468HL3 00000014643HL1 00000014646HL4 00000014647HL2 00000014648HL0 00000014649HL8 00000016626HL4 00000016629HL8 00000016630HL6 00000018158HL6 00000018159HL4 00000018160HL2 00000018163HL6 00000018164HL4 00000018649HL4 00000018733HL6 00000018769HL0 00000018804HL5 00000019142HL9 00000019224HL5 00000019387HL0 00000019550HL3 00000019551HL1 00000019712HL9 00000019748HL3 00000019749HL1 00000019750HL9 00000019751HL7 00000019752HL5 00000019754HL1 00000019855HL6 00000019858HL0 00000019861HL4 00000019925HL7 00000020047HL7 00000020048HL5 00000020049HL3 00000020050HL1 00000020051HL9 00000020053HL5 00000020275HL4 00000020276HL2 00000020277HL0 00000020279HL6 00000020280HL4 00000020281HL2 00000020283HL8 00000020287HL9 00000020289HL5 00000020290HL3 00000020295HL2 00000020297HL8 00000020298HL6 00000020299HL4 00000020300HL0 00000020301HL8 00000020302HL6 00000020304HL2 00000020305HL9 00000020306HL7 00000020307HL5 00000020309HL1 00000020311HL7 00000021375HL1 00000021376HL9 00000021377HL7 00000021916HL2 00000022300HL8 00000022356HL0 00000022359HL4 00000022361HL0 00000022364HL4 00000022365HL1 00000022494HL9 00000022495HL6 00000022499HL8 00000023345HL2 00000023346HL0 00000023356HL9 00000023568HL9 00000023582HLO 00000023582HL0 00000023640HL6 00000023642HL2 00000023643HL0 00000023644HL8 00000023645HL5 00000023706HL5 00000023707HL3 00000023708HL1 00000023932HL7 00000023934HL3 00000023935HL0 00000024598HL5 00000024600HL9 00000024601HL7 00000024602HL5 00000024605HL8 00000024686HL8 00000024695HL9 00000024696HL7 00000024930HL0 00000024932HL6 00000024933HL4 00000024934HL2 00000024935HL9 00000024936HL7 00000025333HL6 00000025395HL5 00000025396HL3 00000025463HL1 00000025464HL9 00000025465HL6 00000025599HL2 00000025601HL6 00000025602HL4 00000025603HL2 00000025604HL0 00000026100HL8 00000026101HL6 00000026102HL4 00000027827HL5 00000027828HL3 00000027830HL9 00000027831HL7 00000027832HL5 00000028087HL5 00000028088HL3 00000028268HL1 00000028392HL9 00000028393HL7 00000028723HL5 00000028764HL9 00000028765HL6 00000028767HL2 00000028893HL6 00000028894HL4 00000028895HL1 00000028896HL9 00000028897HL7 00000029009HL8 00000029011HL4 00000029042HL9 00000029043HL7 00000029200HL3 00000029300HL1 00000029541HL0 00000029542HL8 00000029598HL0 00000029715HL0 00000029716HL8 00000029717HL6 00000029788HL7 00000029789HL5 00000029791HL1 00000029832HL3 00000029833HL1 00000029855HL4 00000029856HL2 00000029894HL3 00000029895HL0 00000029896HL8 00000029897HL6 00000029898HL4 00000029983HL4 00000029984HL2 00000030099HL6 00000030100HL2 00000030154HL9 00000030155HL6 00000030300HL8 00000030478HL2 00000030521HL9 00000030522HL7 00000030524HL3 00000030527HL9 00000030657HL1 00000030872HL6 00000030934HL4 00000031030HL0 00000031058HL1 00000031059HL9 00000031196HL9 00000031197HL7 00000031244HL7 00000031413HL8 00000031474HL0 00000031518HL4 00000031520HL0 00000031521HL8 00000031522HL6 00000031643HL0 00000031647HL1 00000031723HL0 00000031726HL3…

Recall started

Oct. 26, 2011

Device type

System, X-Ray, Stationary

Root cause (FDA)

Device Design

What the company told customers

GE Healthcare sent an Urgent Medical Device Correction letter dated October 24, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to remove the hand grip accessory from use until the product is corrected and to take extra precautions when loading or unloading patients from the table while the hand grips are not in use. A GE Healthcare service representative would contact the consignee to arrange for the correction. For questions regarding this recall call 262-513-4122.

Recall number

Z-1065-2012

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1065-2012. The agency record governs; check it and the company before acting.